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26 days old

Validation Engineer

Kelly Services
Tampa, FL 33603
Kelly Engineering is currently looking to hire a Validation Engineer to work for one of our top Pharma/Medical Device clients on-site in in the Tampa, FL area for a contract position.



This position will perform and support the validation of manufacturing/ packaging equipment, facilities, utilities, computerized systems, temperature-controlled areas/equipment, Media Fills, and sterilization processes associated with the manufacture of pharmaceutical products to assure compliance with cGMPs, Regulatory, and BLPs guidelines.



Responsible for ensuring functional areas, projects, and/or systems are in compliance with Computer System Validation (CSV) and Data Integrity standards and other validation regulatory requirements. The role will provide independent compliance oversight for the systems installed at the site. Job assignments are to be completed without a considerable amount of supervision.



Position will provide coaching and mentoring to other engineers based on experience. Assume the responsibility for the cGMPs and Environmental Health and Safety procedure awareness, and compliance within the respective area.



**KEY ACTIVITIES/RESPONSIBILITIES**




+ Develops sound scientific rationale/strategy for qualification/validation of new or modified cGMP equipment, facilities, computerized systems, temperature-controlled Areas / Equipment, Media Fill, utilities and sterilization processes, as applicable.

+ Design, implement and execute protocols to qualify/validate cGMP equipment, facilities, computerized systems, temperature-controlled Areas / Equipment, Media Fill, utilities and sterilization processes in a manufacturing environment following the latest cGMP regulations.

+ Assess and perform timely process/equipment/systems requalifications and/or revalidations to confirm and provide evidence that such process/equipment/systems remain in a validated state.

+ Evaluate test data and write final reports to summarize testing performed. Gather all pertinent documentation required for completing the validation activity.

+ Coach and mentor less experienced engineers on validation methodology and processes

+ Perform project management duties for limited number of CIP/ compliance related projects.

+ Communicate the requirements, scheduling, results and impact of the performance of the above projects to ensure successful turnover of validated equipment or systems to the customer in support of the manufacture of sterile pharmaceutical product.

+ Identify and participate in continuous improvement projects related to validation programs and procedures.

+ Interface with cross functional teams such as Engineering, Planning, Project Managers, Quality representing validation to help determine impact to validated state and validation strategy for new or modified equipment/ systems/facilities.

+ Assist with regulatory audits/inspections.

+ Provide planning and scheduling support to projects while defining validation scope of work, resources, and duration to meet site-wide validation goals.

+ Review change control documents, work orders, document change requests for assessing impact on validated systems.

+ Open to a flexible and fluid sterile, non-sterile, controlled working Environment.

+ Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing.

+ Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.

+ Perform all other tasks, projects, and duties as assigned

+ Ensure validation program meets requirements of FDA (21 CFR 820 and 21 CFR 11), EU Annex 11, ISO13485:2016 and FDA Data Integrity requirements





**SCOPE**



Assume responsibility for the GMP, environmental health and safety procedure awareness, and compliance within the Validation Department. Expected to stay current with US and international regulations, industry standards, and emerging topics pertaining to computer software validation. Ability to interpret and relate Quality and Best Practice Qualification and Validation standards for implementation and review





**QUALIFICATIONS**




+ Bachelor's Degree in Engineering or any Science Disciplined degree.

+ Minimum 3 years of Engineering or Validation experience.

+ Experience in the following types of validation is desired: Utilities,

+ facilities, manufacturing equipment (compounding, filling, and

+ packaging), sterilization processes including moist heat, dry heat, gamma,

+ and ethylene oxide; Media Fills, temperature-controlled area/equipment.

+ Computerized systems/SQA experience is a plus.

+ Organizational, analytical, computer, writing and communication skills.

+ Knowledge of aseptic processing highly desired.

+ Excellent logical/mechanical aptitude desired.

+ Knowledge of cGMP regulations and latest validation guidelines.

+ Able to handle multiple priorities in a fast-paced environment.

+ Able to work extended/odd hours around manufacturing schedule

+ required.

+ Must be able to read, write, and speak English and possess basic math skills




**Why Kelly** **** **?**



Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-08-24 Expires: 2020-09-24

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Validation Engineer

Kelly Services
Tampa, FL 33603

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